Readers’ picks, responses to Fierce’s ‘Top 10′ cancer drugs report

Posted under BiovaxID, Blog, Cancer Drugs, cancer vaccine, CDX-110, Companies, Diagnostics, Endocyte, Funding, Medical Devices, Medical Supply, Merck, multikine, Pharmaceuticals, Pipeline, rindopepimut, Startups, Universities, Videos, vintafolide by rmcbride

Our readers have really strong feelings about experimental treatments for cancer, and that is one of the reasons that FierceBiotech has encouraged readers to send their feedback on our annual report, Top 10 Late-Stage Cancer Drugs, now in its second year (find last year's report here).

Now find out about several programs that didn't make the cut, much to the dismay of some of our readers.

Below I've tried to capture some of the most interesting responses we've gotten over the past few days since we published our 2012 report. To be clear, we're standing by our top 10 picks and only highlight some of the responses to share with our broader readership the pulse of fervent cancer drug development around the world.

Therapeutic vaccine and immunotherapy fans seem to feel like their favorite programs were overlooked.

We included Amgen's ($AMGN) immunotherapy talimogene laherparepvec (also known as OncoVex), which is in late-stage trials for patients with advanced melanoma. This drug has been a high-flier in cancer vaccine development, in part because Amgen acquired the program in a $1 billion buyout deal with BioVex last year.

Of course, the entire field of therapeutic cancer vaccines has come into question because of the market challenges that Dendreon ($DNDN) has faced with the biotech's pioneering product Provenge. But here are some of the lesser-known cancer immunotherapies that readers asked me to consider for the next report:

-- Rindopepimut, Celldex Therapeutics' ($CLDX) brain cancer vaccine, which is code-named CDX-110. This is the program that Pfizer ($PFE) dumped from its roster of partnerships back in 2010. Still, a reader notes that the EGFRvIII-targeted treatment has advanced into Phase III for primary brain cancer after some promising mid-stage trial data. Read more here.

-- BiovaxID, Biovest International's malignant B cell-targeting therapeutic vaccine. The company recently said it aims to seek approval of the personalized therapy in Canada for treating non-Hodgkin lymphoma. Get more about the plans here.

-- Multikine, Cel-Sci's ($CVM) immunotherapy in late-stage development for treating head and neck cancer. One advantage of the program that a reader noted is that, unlike Dendreon's Provenge, Multikine can be used off-the-shelf and doesn't require cancer patients' cells to be harvested to make the therapy. We'll see how the company's Phase III data look.

Here's an experimental drug that just barely missed the cut for the top 10:

-- Vintafolide, or EC145, Endocyte's ($ECYT) late-stage candidate that combines a chemotherapy drug with a conjugate to home in on cancer cells. Merck ($MRK), of course, just laid down $120 million and committed up to $880 million more in potential payments to gain rights to the program, which has the lead indication of platinum-resistant ovarian cancer.

The "Top 10 Late-Stage Cancer Drugs - 2012" report has only been out for a few days, so I expect we'll get more feedback in the days and weeks to come. I'll plan to tweet some of feedback. -- Ryan McBride (Twitter | email)

Bellicum snags $20M for mid-stage cancer vaccine program

Posted under Bellicum Pharmaceuticals, Blog, cancer vaccine, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Houston-based Bellicum Pharmaceuticals says it has rounded up $20 million to back work on an experimental cancer vaccine. AVG Ventures LP and Remeditex Ventures came in as new investors on the Series B, which is divided into two tranches of $10 million each. The money is intended to fuel the developer's mid-stage plans.

The money will be used to fund a mid-stage study of BPX-101, a cancer vaccine being developed for castration-resistant prostate cancer. The vaccine relies on prostate cancer antigen-expressing dendritic cells which are activated by a proprietary compound to spur an immune response to the cancer.The developer is also planning to launch a Phase I/II study on a T cell infusion product designed to guard against graft vs. host disease.

Tom Farrell, the CEO of Bellicum, noted that the biotech company now has enough money to get through two mid-stage programs, taking it right up to the threshold of pivotal studies. Bellicum boasts of garnering $26 million in committed capital, which includes $6 million from the Cancer Prevention and Research Institute of Texas.  

- here's the release

Gold out, Johnson in as troubled Dendreon aims for a turnaround

Posted under Blog, cancer vaccine, Companies, Dendreon, Diagnostics, Funding, Krystexxa, Medical Devices, Medical Supply, Pharmaceuticals, Provenge, Savient Pharmaceuticals, Startups, Universities, Videos by John Carroll

In the course of one short year, Dendreon CEO Mitch Gold went from biotech hero to zero as the long-anticipated rollout of the groundbreaking cancer vaccine Provenge stumbled badly out of the gate. This morning Gold is out as he moves up to the executive chairman's job for a few months and makes way for Savient CEO John Johnson (pictured), who's had his own travails in 2011 with the troubled launch of the gout drug Krystexxa. Chairman Richard Brewer is out immediately.

Investors responded positively to the change, boosting Dendreon's shares ($DNDN) by 5% this morning.

Provenge's pratfall has been well documented in a series of provider surveys as doctors recoiled from the sticker shock of a $93,000 drug, fretted about their patients' ability to pay increasingly popular co-insurance charges and often concluded that the marginal gain in median survival wasn't worth the expensive effort. New treatments like Zytiga further complicated the picture as Medivation ($MDVN) appears to be hot on Dendreon's heels with a promising new treatment of its own, though the biotech did see a spike in Provenge sales in the fourth quarter of last year. Now Dendreon board member Johnson--who gained credibility after helping in the post-scandal ImClone  turnaround--will be expected to help patch up the marketing end of the business as Dendreon seeks to expand the use of the treatment.

Johnson, though, spent much of 2011 wrestling with Savient's launch of Krystexxa, with only marginal revenue coming in initially. Early on, he created sales teams that offered special support to speed reimbursements from payers. And later he shifted gears, moving past specialists to the broader primary care market. Both Krystexxa and Provenge now offer key cautionary tales for any biotech looking to make the transition from developer to marketer. Those marketing mistakes, and the moves made to overcome them, will be studied closely by developers looking to do better when their turn comes.  

Dendreon has also been working at expanding the use of Provenge, looking for more data to back up its use before patients reach an advanced stage of the disease. Its investigators have just concluded new data analysis that supported its drive to get the treatment used in earlier-stage patient populations.

- read the press release from Dendreon
- get the release from Dendreon on the Provenge data analysis

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Medivation shares skyrocket on positive PhIII prostate cancer data
Dendreon's Gold tops 'Worst Biotech CEO' poll

BioSante axes 25% of workforce after big miss in female libido gel trials

Posted under BioSante Pharmaceuticals, Blog, cancer vaccine, Companies, Diagnostics, FDA, Funding, LibiGel, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Stephen Simes, Universities, Videos by Ryan McBride

BioSante Pharmaceuticals ($BPAX) alerted investors this morning to its plan to move forward after the colossal failure of its late-stage trials for its female libido gel last month. To save cash, the company said it's cutting 21 full-time employees or contractors, about a quarter of its total workforce, and is hunting for in-licensing, merger and acquisition deals.

The Lincolnshire, IL-based drug developer has seen about three quarters of its stock value wiped away after a pair of Phase III studies failed to show that its experimental LibiGel product could beat placebo in treating female sexual dysfunction, for which there are no FDA-approved treatments. The company plans to meet with the FDA to discuss the program and decide within the next three months whether to continue a safety study for LibiGel.

The company's market share stood at a lowly $71.5 million and its stock at 65 cents per share this morning, according to Google Finance.

With the blockbuster hopes for LibiGel all but dashed, BioSante faces questions about what other pipeline contenders can renew faith in the company. Its experimental testosterone gel, licensed to Teva Pharmaceuticals ($TEVA), is under FDA review and the agency is expected to decide whether to approved the treatment by Feb. 14. BioSante also has been studying cancer vaccines in early- and midstage studies for a variety of tumors.

BioSante CEO Stephen Simes has put on a brave face after the LibiGel setback. "Although we are disappointed about the recently reported LibiGel clinical efficacy results, " he said in a statement today. "We are optimistic about the future of BioSante."

Investors don't seem so confident, but we'll see how well Simes can navigate the headwinds that his BioSante faces and renew faith in the company.

- here's the release

Related Articles:
BioSante shares nosedive after libido gel flunks pivotal studies
BioSante's female sexual dysfunction drug draws partnering interest
BioSante's LibiGel passes safety hurdle